To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)
ConditionEwing Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorAnna Raciborska
About this trial
Prospective, interventional, open, randomized, national, multicenter, non-commercial trial
Eligibility criteria
Qualifiers
Histologically proven Ewing sarcoma of the bone or soft tissues.
Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.
Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.
GD2 positive tumor assessed by IHC.
Disqualifiers
Failure to meet any of the inclusion criteria.
Not eligible to IT.
Previous treatment with an anti-GD2 antibody.
Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).
Trial design
Treatments tested in this trial
- Naxitamab
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Anna Raciborska
Lead sponsor
Institute of Mother and Child, Warsaw, Poland
Sponsor institution
Wroclaw Medical University
Collaborator
Source ClinicalTrials.gov